In a standard vaccination programme, single dose vials containing substantially a single dose (e.g. 0.5 ml volume) of a given vaccine are used. Each vial is hermetically sealed on production, for example by a rubber stopper or septum which is inserted into an opening in the vial. The contents of the vial are accessed when required by puncturing the seal with a sterile injection device, such as a syringe, and withdrawing the contents into the injection device. The vial contents may alternatively be withdrawn into a sterile intermediary device for subsequent withdrawal into a sterile injection device. In this manner, the contents remain sterile up to the point of injection into a subject.
Vials containing more than a single dose of a medicament are known as multidose vials. Various such multidose vials are well known in the art. A typical example is illustrated in FIG. 1 and described in greater detail below under the section entitled “Vials”.
As set out in greater detail below under the section entitled “ISO Standards for Vials”, vials are subject to ISO standards including ISO 8362-1, ISO 8632-2, ISO 8632-3 and ISO 8632-4.
A problem associated with multidose vials is that once the seal has been penetrated in order to withdraw a first dose from the vial, the chamber may no longer be sterile. For example, penetrating a seal with an injection device could leave a puncture hole in the seal. Alternatively, where a self-sealing type of seal, such as a septum, is used, fragmentation problems might occur. An example of such fragmentation problems includes the dislodgement of a fragment of the septum into the chamber on insertion of the injection device. After removal of the first dose, therefore, the contents may lose sterility.
Sterility may be maintained by the use of a component within the vial contents which may include preservatives such as thiomersal or 2-phenoxyethanol. It is preferred, however, that the components should be substantially free from preservatives, and an objective of the invention is to maintain sterility in a multidose vial during and after the withdrawal of a first dose therefrom, without the use of preservatives within the vial contents.
As disclosed in WO2008/117178, entitled “Multidose Vial Adapter”, sterility may also be maintained by the use of a sterile withdrawal spike. Such sterile withdrawal spikes are known in the art. One example is the Mini Spike™ produced by B. Braun™. A typical example of a sterile spike 30 is illustrated in FIG. 2 and disclosed in US2002/0040206. Interior details are illustrated in FIG. 10. Further details are set out below in the section entitled “Sterile Spike”.
The various problems identified under “Sterile Spike” are addressed in WO2008/117178, by the provision of an adapter 60 to interconnect a multidose vial 10 with a withdrawal spike 30. The adapter is described in detail below under the section entitled “The adapter of ‘Multidose Vial Adapter’”.
A potential problem with the solution proposed in WO 2008/117178 has been envisaged, however. Automated interconnection of the three component parts might be difficult to achieve in some circumstances. Whereas automated coupling of the withdrawal spike 30 to the adapter 60 might be achievable, the subsequent step of coupling the assembled adapter 60 with withdrawal spike 30 coupled thereto to the vial 10 is likely to be practically unachievable in an automated manner. This has the consequence that at least the vial 10 will be supplied without having been assembled together with the other component parts of the assembly. Assembly will therefore take place at the point of use, e.g. at a clinic.
Point of use assembly can be unsatisfactory; firstly because there remains scope for incorrect assembly of the component parts by underskilled personnel, for example; and secondly because the component parts must be supplied separately. Hence, there is a risk that the parts could become separated (even if supplied together) which may result in preservative-free vials intended for use only with a sterile withdrawal spike and adapter being confused with vials containing preservative. This could then result in contaminated doses being inadvertently administered.
To that end, it is an objective of the invention to simplify the interconnection required between the component parts so that they can be supplied pre-assembled.